Editor's note: This post was updated Feb. 3, 2016, at 12:25 pm to include a statement from the Food and Drug Administration and a comment from Mark Sauer.
Would it be ethical for scientists to try to create babies that have genetic material from three different people? An influential panel of experts has concluded the answer could be yes.
The 12-member panel, assembled by the National Academies of Sciences, Engineering and Medicine, released a 164-page report Wednesday outlining a plan for how scientists could ethically pursue the controversial research.
"The committee concludes that it is ethically permissible" to conduct such experiments, the report says, but then goes on to detail a long list of conditions that would have to be met first.
For example, scientists would have to perform extensive preliminary research in the laboratory and with animals to try to make sure it is safe. And then researchers should initially try to make only male babies, because they would be incapable of passing their unusual amalgamation of DNA on to future generations.
"Minimizing risk to future children should be of highest priority," the committee writes.
The report was requested by the Food and Drug Administration in response to applications by two groups of scientists in New York and Oregon to conduct the experiments. Their goal is to help women have healthy babies even though they come from families plagued by genetic disorders.
A statement issued by the FDA immediately after the report's release raised questions about whether the FDA would permit the research to move forward.
The FDA email praised the "thoughtful work" of the panel and said the agency would be "reviewing" the recommendations. But it noted that the latest federal budget "prevents the FDA from using funds to review applications in which a human embryo is intentionally created or modified to include" changes that could be passed down to future generations. As a result, the email says, any such research "cannot be performed in the United States" at this time.
The researchers pursuing these experiments welcomed the panel's conclusions.
"I think it's a great step in the right direction," Mark Sauer, a professor of obstetrics and gynecology at Columbia University who is a member of one of the teams, said of the National Academies report in an interview before the FDA issued its statement.
Sauer called the report more of a "yellow light" than a "green light," because of the long list of caveats and cautions. But that is "better than a red light," he says.
"Most importantly to us is that it allows the work to continue to hopefully produce children without these disorders," Sauer says.
But Sauer said he was disappointed when he learned of the FDA's response.
"Politics as usual often gets in way of progress," Sauer said in a subsequent email. While the FDA statement would cause "undue delays" in his research, he added that he hoped it wouldn't permanently "necessarily halt the efforts."
Critics of the research, meanwhile, say the number of women who could benefit from the experiments is so small that it's not worth crossing a line that's long been considered off-limits — making genetic changes that could be passed down for generations.
"The possibility of what you could call 'mission creep' is very real," says Marcy Darnovsky, executive director of the Center for Genetics and Society, a watchdog group based in Berkeley, Calif. "People are talking about going forward not just with this but with the kind of genetic engineering that will produce outright genetically modified human beings."
Once that happens, Darnovsky says, "I think you get into a situation of where some people are genetically enhanced and other people are the regular old variety of human being. And I don't think that's a world we want to live in."
The goal of the research is to help women carrying diseases known as mitochondrial disorders, which are only passed down by women through defects in the genetic material in their eggs.
Specifically, the defects are in a type of genetic material known as mitochondrial DNA.
Unlike the DNA that most people are familiar with — the 23 pairs of human chromosomes that program most of our body processes and traits — mitochondrial DNA consists of just 37 genes inside mitochondria, which are structures inside cells that provide their energy.
Mitochondrial disorders range from mild to severe. In many cases there is no treatment, and the affected child dies early in life after suffering progressive, debilitating symptoms.
Scientists want to create eggs free of mitochondrial defects by removing the defective mitochondrial DNA. It would be replaced with healthy mitochondrial DNA from eggs donated by other women.
The British government recently approved such experiments in that country.
But this remains controversial, not only due to the fact that the resulting children would have DNA from three people. Because the transplanted DNA could be passed down for generations, critics fear it could accidentally introduce errors into the human gene pool that could create new diseases.
They also worry it would set a precedent that could open the door to creating designer babies, in which parents can pick and chose the traits of their children.
Because of such concerns, making any change in DNA that could be passed down for generations has long been considered off-limits.
The committee report acknowledged that making babies with DNA from three different people could have "psychological and social effects" on the offspring, including issues about their "conception of identity."
In addition, the committee acknowledged the possibility that it could lead to attempts at genetic "enhancements."
Such work would raise thorny regulatory issues, the committee noted. For example, the federal government is prohibited from funding research that involves destroying human embryos. As a result, "even an agency request" for data from such research in support of FDA approval "could well be controversial," the report says.
Nevertheless, the committee says the potential benefits make the work worth pursuing with careful oversight.
Moreover, the FDA could at some point even consider letting experiments proceed to try to create female babies if certain criteria are met, the report said, including the production of "clear evidence of safety and efficacy from male" experiments and signs that it would be publicly acceptable.
KELLY MCEVERS, HOST:
And now a story about some controversial medical research. Scientists want to create babies that would be born with DNA from three different people. The National Academy of Sciences today said experiments could proceed ethically, even though it raises many sensitive issues. Then, the Food and Drug Administration said it could not let that happen. NPR health correspondent Rob Stein joins us in the studio to sort this out. And, Rob, let's start off with some basics here. What exactly do scientists want to do here and why?
ROB STEIN, BYLINE: Well, Kelly, this is all aimed at trying to help certain women have healthy babies. And these are women who have defects in a tiny but really important kind of DNA known as mitochondrial DNA. And this DNA - defects in this DNA can cause some terrible diseases, so scientists want to do what you could sort of think of as a DNA transplant on eggs in the laboratory to help these women. What they would do is they would replace this defective DNA with healthy DNA from eggs donated by other women. And then these eggs would be fertilized in a laboratory with sperm, and that would allow women to have children that would have mostly all of their genes and all the genes that most people think are important - the genes from how we look, like how tall we are and what our eye color is and hair color is.
MCEVERS: I mean, as we said, though, this is pretty controversial, right?
STEIN: It's really controversial for lots of reasons. And the first one is this would be the first time that anybody's ever tried this sort of thing in people. So a big question is, you know, is it safe? And then, another question is what you raised in the introduction, which is these - any kids born this way would have DNA from three different people - from the woman who donated the healthy mitochondrial DNA, from the woman who's trying to have the healthy baby and from the man whose sperm is used to fertilize the egg in the laboratory. And that raises all kinds of issues about identity. I mean, these would be the first people in the world created this way. What would these kids think about themselves, who they are, who their parents are?
MCEVERS: Right. I mean, even if the babies were then born healthy by using this method, are there longer-term issues that we might think about - need to think about?
STEIN: Yeah, sure. Actually, the really big concern about all this is that this would be the first time that scientists would be allowed to make changes in human DNA that could be passed down for generations. That's never been allowed before. That's been considered off-limits, you know - and - because, you know - but in this case, any women who have female children born - created this way will then pass this mix of genes on to any future women that are born this way and so on so forth for future generations. And that raises all kinds of concerns. A big one is that, you know, scientists could make some sort of mistake...
STEIN: ...and introduce some new disease into the human gene pool or that scientists could try to do this for other reasons - nonmedical reasons, like create designer babies where parents pick the traits of their children.
MCEVERS: Oh, boy.
STEIN: And that starts to raise all kinds of issues about genetically engineering the human race.
MCEVERS: Yeah. I mean, as we mentioned, the National Academy of Sciences today said experiments could proceed despite the sensitivity and the controversy. Why did it look at this, and what else did it say?
STEIN: Yeah. So what happened is there are these scientists in New York and Oregon who asked the FDA if they could do this. The FDA started to look at it and realized they'd raised all these really vexing issues and so decided it should ask the National Academy of Sciences for some guidance. The academy took a deep dive into the issue and today came back with its conclusions, which is that, yes, it could be ethically permissible to pursue this research, but only very carefully. And what they mean by that is you'd have to do a lot of research first to make sure it's safe, and they also suggested that you only start by doing this to create male offspring. And males could not pass these mix of genes onto future offspring...
MCEVERS: Oh, OK.
STEIN: ...So that would sidestep all these scary issues we've been talking about.
MCEVERS: Very quickly - what happens now?
STEIN: So, you know, the scientists who want to do this were thrilled by this recommendation. They thought it could finally allow them to help these women who are plagued by these terrible diseases, but the FDA came in and reminded everybody that the latest federal budget has language that specifically prohibits them from even considering this. So it's all in limbo, for now at least.
MCEVERS: That's NPR health correspondent Rob Stein. Thanks so much.
STEIN: Oh, sure. Thanks for having me. Transcript provided by NPR, Copyright NPR.